Web-based Psycho-Educational Program to Support Carers of Alzheimer's Patients (DIAPASON)
2018年3月16日 更新者：Assistance Publique - Hôpitaux de Paris
Evaluation of a Web-based Psycho-Educational Program for Informal Caregivers of Patients With Alzheimer's Disease (AD).
The aim of the project is to evaluate the efficacy of a web-based psycho-educational programme designed to support informal caregivers of patients with Alzheimer's disease (AD).This program focuses on information about the illness, her progression, how to prevent psychological strain using anticipation and relaxation techniques and providing a virtual space (forum) to discuss with other caregivers.
調査の概要
状態
完了
条件
詳細な説明
Context: Since some of the ICs do not have the possibility to participate in face-to-face interventions, information and communication technologies are being increasingly used for a distance intervention. Research showing the benefit of a combined approach including psycho-social interventions for caregivers and Information and Communication Technologies (ICT) in the caring of Alzheimer's disease patients is actually growing. Main objective: To evaluate the efficacy of a a web-based psycho-educational program designed to support carers of AD patientsMethodology: This is a randomized clinical trial . 80 participants will be randomized in 2 parallel groups: The volunteers in the experimental condition (EC) should visit at least one time per week the website of program, during 12 weeks. Each week a new thematic is added to the website. b) The participants in the control group (CG) will receive a minimal intervention, and will have access to the Diapason program after their participation (six months). Caregivers are recruited (according to exclusion and inclusion criteria) and followed up in memory center participating in the trial.
Evaluation criteria:
Primary criteria:
- Perceived Stress Scale (PSS-14).
Secondary evaluation criteria:
- Nottingham Health Profile (NPH),
- Zarit Burden Interview (BI),
- Revised Memory and Behavior Problems Checklist (RMBPC),
- Beck Depression Inventory (BDI-2) Mediator variables
- Revised Scale for Caregiving Self-Efficacy (RCSE).
- Statistics of website utilization Controlled variables
- Sociodemographic variables (Self report)
- Knowledge about illness (Visual analogical scale - VAS)
- The quality of the relationship with the patient (VAS)
- Time spent on caregiving
- Other sources of stress (i.e. work, health status, financial status)
- Respite or social help (i.e. psychotherapy, associations, technical help, etc)
- Cognitive and autonomy status of patient (MMSE and IADL)
Statistical analysis by the department of biostatistics and medical computing of the Hospital Cochin will be performed.
研究の種類
介入
入学 (実際)
49
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Paris、フランス、75013
- Hôpital Broca - la Collégiale, Geriatric Unit, Memory Clinic
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion criteria :
- Family caregivers of AD patients DSM IV-TR (American Psychiatric Association 2004) or NINCDS/ADRDA (McKhann et al. 1984).
- Age: over 18 years old
- score 12 or over on the Perceived Stress Scale 14 items (PSS-14, Cohen) Need for information or help
- Sign informed consent
Exclusion criteria :
- Professional or paid caregiver
- Physical or mental disease incompatible with patient's management
- Impossibility to participate in the educational program
- Absence of perceived stress
- Ongoing psychotherapy or a similar program in parallel
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：Psycho-educational program
This group is trained for a 3 month period by a web-based psycho-educational program, Lifestyle Counseling, etc.
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This group will be trained for a 3 month period by a web-based psycho-educational program, Lifestyle Counseling, etc.
他の名前：
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アクティブコンパレータ：Standard treatment
This group will receive treatment as usual : consultation in memory clinic every 6 months during the AD patient's consultation.
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This group will receive treatment as usual (consultation in memory clinic every 6 months)
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Perceived stress
時間枠：every 3 months (between 0 and 6 months)
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Stress perceived by the caregiver is measured by the French version of the Perceived Stress Scale, the version of 14 items from Cohen and colleagues (1983), traduced to by Bruchon-Schweitzer in 2002.
The PSS-14 is a widely used self-reported scale, evaluating the general appraisal of stress in the last month.
It consists in 14 items, which scores range from 0 (never) to 4 (very often).
This scale has demonstrated a high reliability and validity in several studies.
The total score range is 0-56.
In this study CG and EC will perform the scale at baseline (month 0), at the end of intervention for EC (month 3) and follow-up (month 6).
Participants from control group will receive an acces to the program at the end of the last visit (M6).
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every 3 months (between 0 and 6 months)
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Nottingham Health Profile (NPH)
時間枠：every 3 months (between 0 and 6 months)
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every 3 months (between 0 and 6 months)
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ZARIT Burden Interview (BI)
時間枠：every 3 months (between 0 and 6 months)
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every 3 months (between 0 and 6 months)
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Revised Memory and Behavior Problems Checklist (RMBPC)
時間枠：every 3 months (between 0 and 6 months)
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every 3 months (between 0 and 6 months)
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Beck Depression Inventory (BDI-2)
時間枠：every 3 months (between 0 and 6 months)
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every 3 months (between 0 and 6 months)
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Revised Scale for Caregiving Self-Efficacy (RCSE)
時間枠：every 3 months (between 0 and 6 months)
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every 3 months (between 0 and 6 months)
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
協力者
捜査官
- 主任研究者：Anne-Sophie Rigaud, MD, PhD、Hôpital Broca - la Collégiale, Memory Clinic
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
- Cummings JL, Mega M, Gray K, Rosenberg-Thompson S, Carusi DA, Gornbein J. The Neuropsychiatric Inventory: comprehensive assessment of psychopathology in dementia. Neurology. 1994 Dec;44(12):2308-14. doi: 10.1212/wnl.44.12.2308.
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- Lyketsos CG, Steinberg M, Tschanz JT, Norton MC, Steffens DC, Breitner JC. Mental and behavioral disturbances in dementia: findings from the Cache County Study on Memory in Aging. Am J Psychiatry. 2000 May;157(5):708-14. doi: 10.1176/appi.ajp.157.5.708.
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- Zarit SH, Todd PA, Zarit JM. Subjective burden of husbands and wives as caregivers: a longitudinal study. Gerontologist. 1986 Jun;26(3):260-6. doi: 10.1093/geront/26.3.260. No abstract available.
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- Ankri J, Andrieu S, Beaufils B, Grand A, Henrard JC. Beyond the global score of the Zarit Burden Interview: useful dimensions for clinicians. Int J Geriatr Psychiatry. 2005 Mar;20(3):254-60. doi: 10.1002/gps.1275.
- Bourgeois MS, Schulz R, Burgio L. Interventions for caregivers of patients with Alzheimer's disease: a review and analysis of content, process, and outcomes. Int J Aging Hum Dev. 1996;43(1):35-92. doi: 10.2190/AN6L-6QBQ-76G0-0N9A.
- Brodaty H, Green A, Koschera A. Meta-analysis of psychosocial interventions for caregivers of people with dementia. J Am Geriatr Soc. 2003 May;51(5):657-64. doi: 10.1034/j.1600-0579.2003.00210.x.
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- Gallagher-Thompson D, Coon DW. Evidence-based psychological treatments for distress in family caregivers of older adults. Psychol Aging. 2007 Mar;22(1):37-51. doi: 10.1037/0882-7974.22.1.37.
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- Magnusson L, Hanson E, Brito L, Berthold H, Chambers M, Daly T. Supporting family carers through the use of information and communication technology--the EU project ACTION. Int J Nurs Stud. 2002 May;39(4):369-81. doi: 10.1016/s0020-7489(01)00034-7.
- Mittelman MS, Roth DL, Haley WE, Zarit SH. Effects of a caregiver intervention on negative caregiver appraisals of behavior problems in patients with Alzheimer's disease: results of a randomized trial. J Gerontol B Psychol Sci Soc Sci. 2004 Jan;59(1):P27-34. doi: 10.1093/geronb/59.1.p27.
- Ramaroson H, Helmer C, Barberger-Gateau P, Letenneur L, Dartigues JF; PAQUID. [Prevalence of dementia and Alzheimer's disease among subjects aged 75 years or over: updated results of the PAQUID cohort]. Rev Neurol (Paris). 2003 Apr;159(4):405-11. French.
- Schulz R, Beach SR. Caregiving as a risk factor for mortality: the Caregiver Health Effects Study. JAMA. 1999 Dec 15;282(23):2215-9. doi: 10.1001/jama.282.23.2215.
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2011年10月1日
一次修了 (実際)
2014年5月1日
研究の完了 (実際)
2014年7月1日
試験登録日
最初に提出
2011年8月22日
QC基準を満たした最初の提出物
2011年9月7日
最初の投稿 (見積もり)
2011年9月8日
学習記録の更新
投稿された最後の更新 (実際)
2018年3月19日
QC基準を満たした最後の更新が送信されました
2018年3月16日
最終確認日
2014年7月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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